NA 03.617.993Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10705034717401), received between Feb 7, 2017 and Dec 30, 2024 — classified as 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (11 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT AT THE MOMENT OF PASSING THE AWL AND THE DRILL BIT, THE FIRST PIECE BROKE AND THE SECOND TWISTED. THERE WAS NO PATIENT HARM. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21036913 ↗
• MalfunctionSep 11, 2024Break; Break

  IT WAS REPORTED THAT WHILE THE SURGEON WAS DOING A THREE LEVEL ACDF (ANTERIOR CERVICAL DISCECTOMY AND FUSION) ON (B)(6) 2024, AS HE WAS WORKING ON C5-C6 HE WAS USING THE ANGLED AWL IN THE ZERO P SET, AND THE TIP BROKE OFF INTO THE VERTEBRAE BODY. ALL PIECES WERE RETRIEVED FROM THE PATIENT. NO HARM WAS DONE TO THE PATIENT. ANOTHER ANGLED AWL WAS USED AND THE CASE WAS SUCCESSFULLY FINISHED WITH ONLY A MINUTE DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE GREAT. NO OTHER INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20191401 ↗
• MalfunctionMar 1, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 DURING AN INSPECTION AT THE LOANER SET DEPARTMENT AT LOC UMKIRCH, IT WAS NOTICED THAT THE ITEM WAS FRAGILE. THERE WAS NO SURGERY OR PATIENT IMPACT. DURING INSPECTION ON FEBRUARY 16, 2023, THE ITEM WAS DISCOVERED TO BE BROKEN. THIS REPORT INVOLVES ONE 2.0MM ANGLED AWL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16458997 ↗
• MalfunctionFeb 8, 2023Break; Break

  THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16328627 ↗
• MalfunctionJun 24, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT AWL TIP (03.617.993) BROKE OFF DURING PROCEDURE. WHILST USING THE ZERO P ANGLED AWL TO CREATE A PATHWAY FOR THE SCREW, THE TIP OF THE AWL BROKE OFF. THE BROKEN FRAGMENT WAS RETRIEVED FROM THE PATIENT AND PROCEDURE WAS COMPLETED WITH NO DELAY. THIS COMPLAINT INVOLVES ONE (1) DEVICE AWL Ø2 ANGL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14804343 ↗
• InjuryJun 9, 2022Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING A PROCEDURE THE PUNCH BREAKS DURING BONE PERFORATION, A FRAGMENT REMAINS INSIDE THE PATIENT IN THE VERTEBRAL BODY. THE SCREWDRIVER BROKE WHEN THE DOCTOR WAS INSERTING THE SCREW INTO THE BONE, HE FINISHED PUTTING THE SCREW WITH A STRAIGHT SCREWDRIVER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) 2.0MM ANGLED AWL. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 14642609 ↗
• MalfunctionJun 9, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A SURGERY ON (B)(6), 2021, THE SCRUB PICKED UP THE ANGLED AWL TO GIVE TO THE SURGEON AND NOTICED THAT THE TIP OF THE ANGLED AWL WAS BROKEN OFF. THE SCRUB THEN HANDED UP THE STRAIGHT AWL AND THE SURGEON USED IT TO AWL THE PILOT HOLES BEFORE INSERTING THE SCREWS. THE PATIENT DID NOT SUFFER ANY CONSEQUENCES NOR EXTRA TIME WAS SPENT IN SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 2.0MM ANGLED AWL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11970105 ↗
• MalfunctionMay 4, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN THAT THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, WHEN USING THE AWL FOR THE SCREW HOLE IN THE PATIENT, THE SURGEON PULLED OUT THE AWL AND THE SHARP TIP OF THE AWL WAS STILL IN THE SCREW HOLE. THE SURGEON USED FORCEPS TO PULL OUT THE AWL TIP. THERE WAS NO DELAY REPORTED. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN ZERO PROFILE SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 2.0MM ANGLED AWL THIS REPORT IS 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11771823 ↗
• MalfunctionApr 14, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN UNKNOWN PROCEDURE, THE 2.0MM ANGLED AWL BROKE. THERE WAS NO SURGICAL DELAY REPORTED. THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) 2.0MM ANGLED AWL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11666871 ↗
• MalfunctionJan 6, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A PROCEDURE WHEN THE SURGEON REMOVED THAT AWL, THE AWL BROKE OFF IN THE PATIENT. THE SURGEON USED FORCEPS TO REMOVE THE FRAGMENTS FROM THE PATIENT. THE FRAGMENTS WERE EASILY REMOVED. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE STRAIGHT AWL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A SURGICAL DELAY OF TWO (2) MINUTES. THIS REPORT INVOLVES ONE (1) 2.0MM ANGLED AWL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11124499 ↗
• InjuryDec 14, 2020Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THAT THE ZERO-P END OF THE AWL BROKE WHILE IT USING IT. THERE WAS A SURGICAL DELAY OF TWENTY (20) MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) 2.0MM ANGLED AWL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11005550 ↗
• MalfunctionJul 15, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DURING AN ANTERIOR CERVICAL DISCECTOMY PROCEDURE ON AN UNKNOWN DATE, THE ANGLED STARDRIVE SCREWDRIVER AND THE 2.0MM ANGLED AWL WERE NOT ADEQUATE TO PROPERLY CREATE A SCREW PATH AND INSERT THE SCREW. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH 5 MINUTES SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES 2 DEVICES. THIS REPORT IS FOR 1 DESCRIPTION OF PART. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10276156 ↗
• InjuryFeb 7, 2017Break; Break

  IT WAS REPORTED THAT AFTER PLACEMENT OF ZERO-PROFILE VARIABLE ANGLE (ZERO-P VA) SPACER WITH INTERBODY PLATE THE FIRST SCREW HOLE WAS PREPARED WITH THE ANGLED AWL DURING SURGERY ON (B)(6) 2017. WHEN TURNING OUT WITH SLIGHT ROTATION, POSSIBLY LIGHT LEVER, THE TIP OF THE AWL BROKE OFF AND HAS BEEN LEFT IN THE VERTEBRAL BODY. NO REMOVAL SURGERY PLANNED YET. THEREFORE, THE ZERO-P VA COULD ONLY BE FIXED WITH ONE SCREW. THERE WAS NO PROLONGATION OF SURGERY. COMPLAINT INVOLVES 1 PART. REPORTED CONCOMITANT DEVICES: ZERO-P VA SPACER WITH INTERBODY PLATE (PART: 04.647.129S, LOT: 9370106, QUANTITY: 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 6309625 ↗